Adoptive Transfer of Haploidentical Natural Killer Cells to Treat Refractory or Relapsed AML MT2010-02

NCT01106950 Phase 2 TERMINATED Results posted

This is a phase II therapeutic study of related donor HLA-haploidentical NK-cell based therapy after a high dose of fludarabine/cyclophosphamide with denileukin diftitox preparative regimen for the treatment of poor prognosis acute myelogenous leukemia (AML).

Details

Lead sponsor	Masonic Cancer Center, University of Minnesota
Phase	Phase 2
Status	TERMINATED
Enrolment	15
Start date	2010-07
Completion	2012-12

Conditions

• Leukemia, Myelogenous, Acute

Interventions

• Natural Killer Cells
• Fludarabine
• Cyclophosphamide
• Denileukin diftitox
• Donor lymphapheresis
• IL-2

Primary outcomes

• Percent of Patients With Successful Expansion of Natural Killer Cells After Infusion — Day 14
  The primary objective of this study was to estimate the incidence of in vivo expansion of natural killer (NK) cells 14 days after infusion of an allogeneic donor product enriched for NK progenitors. Successful in vivo donor NK cell expansion was defined by measuring an absolute circulating donor-derived NK cell count of \>100 cells/ul in the patient's peripheral blood 14 days after infusion.

Countries

United States